Boston Scientific Neuromodulation Corporation: Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035

Company / brand

Boston Scientific Neuromodulation Corporation

Product

Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU, INTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045, INTRACEPT ACCESS INSTRUMENTS- 2VB EU/RLV0045-EU, INTRACEPT ACCESS INSTRUMENTS- 3VB/RLV0055, INTRACEPT ACCESS INSTRUMENTS- 3VB EU/RLV0055-EU, INTRACEPT ACCESS INSTRUMENTS 2 VB/RLV0065, INTRACEPT ACCESS INSTRMNTS ADDITIONAL VB/RLV0075, INTRACEPT ACCESS INSTRMNTS ADDTL VB EU/RLV0075-EU

Reason / hazard

Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.

Classification

Class II

Status

Ongoing

Distribution / sold at

Worldwide - US Nationwide distribution including in the states of NJ, WI, MI, MN, AR, UT, OH, FL, CA, TX, PA, AZ, IN, LA, NE, OK, NY, MD, WY, CO, NC, IL, GA, WA, KS, AL, MO, VA, TN, KY, MS, MA, SC, OR, WV, MT, ID, SD, CT, NV, ND, NH, DE, NM, AK, IA, DC, HI, ME, VT, RI and the countries of Great Britain, Germany, United Arab Emirates.

Recall initiated

2026-04-22

Code info

REF/UDI-DI/Lot/Expiration Date Range: RLV0035/852454006240/36231634, 36266333, 36266334, 36266335, 36442451, 36556998, 36577474, 36577475, 37355534, 37374614, 37642257, 37642258, 37667047, 37667049, 38711750, 38711751/04-Mar-2027 to 21-Jul-2027; RLV0035-EU/852454006448/36267790, 36909569, 38889437/04-Mar-2027 to 26-Jun-2027; RLV0045/852454006301/35218150, 35218151, 35218152, 35218153, 35219469, 35219470, 35229010, 35229011, 35229012, 35256597, 35318740, 35318741, 35318742, 35329853, 35329854, 35338734, 35360990, 35360991, 35360992, 35406849, 35406850, 35406851, 35406852, 35406853, 35406854, 35498172, 35508065, 35508066, 35523483, 35523484, 35525666, 35535444, 35535445, 35535446, 35535664, 35535665, 35536282, 35538112, 35538113, 35538114, 35538115, 35717797, 35717798, 35717861, 35729587, 35729588, 35729589, 35738091, 35738092, 35738093, 35755411, 35755412, 35755413, 35788378, 35788379, 35788400, 35789578, 35789579, 35789840, 35822293, 35822294, 35822295, 35831721, 35831722, 35831723, 35884013, 35884014, 35884015, 35884018, 35884019, 35884200, 35929731, 35929732, 35929733, 35939403, 35939404, 35939405, 36007510, 36051631, 36051632, 36051633, 36061072, 36061073, 36063527, 36115270, 36115271, 36162140, 36201849, 36211661, 36211662, 36247081, 36247082, 36247083, 36299784, 36299785, 36306155, 36306908, 36312074, 36312075, 36312076, 36327640, 36327641, 36334682, 36334683, 36334684, 36337568, 36337569, 36356333, 36368650, 36368651, 36390837, 36390839, 36390960, 36390962, 36390963, 36411346, 36440610, 36440611, 36451984, 36455377, 36455378, 36528101, 36538547, 36538548, 36554903, 36576169, 36576170, 36576171, 36578105, 36578106, 36578107, 36578108, 36709018, 36714451, 36719971, 36731035, 36731036, 36731037, 36733644, 36733645, 36743247, 36743248, 36765841, 36765842, 36765843, 36778439, 36779700, 36779701, 36789363, 36789364, 36793775, 36793776, 36802652, 36802653, 36802654, 36814178, 36819483, 36819484, 36825817, 36835476, 36839951, 36839952, 36892404, 36892405, 36907158, 36920578, 36931525, 36938443, 36938444, 36938445, 36948565, 36965128, 36977051, 36984738, 37006934, 37006935, 37021399, 37038790, 37060446, 37072745, 37072746, 37115658, 37126596, 37126597, 37143684, 37143685, 37182176, 37182177, 37191624, 37203924, 37210305, 37222391, 37222392, 37248543, 37248544, 37257912, 37278064, 37278065, 37291738, 37422836, 37422837, 37422838, 37434285, 37434286, 37443230,37467700, 37467701, 37467702, 37499290, 37499291, 37513740, 37513741, 37527332, 37558530, 37558531, 37586529, 37604798, 37604928, 37752893, 37752894, 37808050, 37808051, 37818544, 37818545, 37818546, 37864351, 37864352, 37876714, 37876715, 37876716, 37876717, 37909770, 37909771, 37923968, 37941727, 37941728, 38243913, 38243914, 38243915, 38253672, 38253673, 38253674, 38253675, 38257979, 38258120, 38258121, 38393517, 38393518, 38461277, 38461278, 38462080, 38462081, 38462082, 38462587, 38472779, 38473000, 38473001, 38473954, 38484605, 38484606, 38496711, 38517754, 38531680, 38600809, 38600810, 38600811, 38600812, 38632672, 38632673, 38632674, 38711753, 38712187, 38917000, 38917002, 39009366/03-Oct-2026 to 03-Mar-2028; RLV0045-EU/852454006431/36190488, 36254922, 36411351, 36909570, 37575379, 38654200/11-Feb-2027 to 04-Nov-2027; RLV0055/852454006226/35235794, 35235795, 35235796, 35235797, 35235798, 35235799, 35235940, 35244678, 35244679, 35245420, 35265922, 35309126, 35309128, 35309130, 35316016, 35328273, 35328274, 35367311, 35367312, 35367313, 35453674, 35461292, 35461293, 35461294, 35461295, 35461296, 35469325, 35469326, 35469327, 35498173, 35498174, 35508414, 35508415, 35516633, 35518863, 35518864, 35520116, 35522815, 35522816, 35522817, 35522818, 35530433, 35530434, 35582150, 35582151, 35582152, 35585353, 35585354, 35590649, 35590650, 35738094, 35738095, 35738096, 35738097, 35738098, 35738099, 35780448, 35780449, 35780450, 35789910, 35789911, 35789912, 35796422, 35796423, 35796424, 35831784, 35831785, 35831786, 35841864, 35841865, 35841866, 35849369, 35849370, 35849371, 35871196, 35871197, 35871198, 35890764, 35890765, 35890766, 35989202, 35989203, 35989204, 36042033, 36042034, 36042035, 36051634, 36051635, 36051636, 36103927, 36103928, 36103930, 36168356, 36201850, 36254923, 36254924, 36258582, 36299786, 36299787, 36306157, 36306158, 36306159, 36315014, 36315015, 36327258, 36327259, 36334687, 36334688, 36334689, 36346737, 36346738, 36346739, 36346800, 36356510, 36356511, 36368652, 36368653, 36377745, 36421406, 36421407, 36421408, 36442449, 36442450, 36455379, 36466553, 36466554, 36474482, 36509579, 36509640, 36511507, 36518452, 36518454, 36519641, 36519642, 36538550, 36588268, 36588269, 36588270, 36588271, 36588273, 36627806, 36779702, 36779703, 36779704, 36789365, 36796277, 36796278, 36801923, 36879218, 36879219, 36879300, 36885626, 36885627, 36948834, 37018069, 37018070, 37021397, 37021398, 37030573, 37038794, 37060447, 37072747, 37072748, 37072749, 37085884, 37085885, 37097347, 37097348, 37097349, 37097352, 37105997, 37105998, 37114545, 37143682, 37143683, 37234124, 37234125, 37248545, 37266940, 37266941, 37278066, 37291818, 37291819, 37422839, 37423650, 37423651, 37434287, 37434288, 37476160, 37476161, 37486544, 37513375, 37513376, 37517300, 37527333, 37527334, 37527335, 37528240, 37528241, 37548528, 37548529, 37548530, 37548532, 37576081, 37586522, 37586530, 37597563, 37597564, 37606989, 37606990, 37606992, 37723478, 37752895, 37752896, 37752897, 37771990, 37771991, 37771993, 37772123, 37772124, 37772125, 37864353, 37864354, 37864355, 37885352, 37885353, 37930763, 37930764, 37930765, 37954165, 37954166, 37954167, 37954168, 38048470, 38196327, 38196328, 38243169, 38243170, 38252987, 38252988, 38252989, 38287216, 38287217, 38287218, 38404416, 38462594, 38474849, 38474880, 38474881, 38481950, 38481954, 38483325, 38496708, 38496709, 38529820, 38531658, 38531659, 38537775, 38540454, 38540782, 38540792, 38614681, 38711754, 38712189/10-Oct-2026 to 29-Oct-2027; RLV0055-EU/852454006318/36190489/30-Jan-2027 to 30-Jan-2027; RLV0065/852454006424/37166269, 37166270, 37205965, 37422790, 37422791, 37434847, 37434848, 37822997, 37822998, 37822999, 37837635, 37837636, 37837637, 37859920, 37903427, 37903428, 37909761, 37930774, 37930775, 37980230, 37980231, 37980232, 37980233, 38079204, 38079205, 38079206, 38079207, 38107765, 38107766, 38107767, 38107768, 38135922, 38135923, 38135924, 38154984, 38154985, 38159015, 38166823, 38166824, 38166825, 38166826, 38166827, 38166828, 38169819, 38170180, 38170693, 38170694, 38205657, 38205658, 38205659, 38222326, 38222327, 38222328, 38222329, 38222330, 38243916, 38339417, 38339418, 38339419, 38339880, 38339881, 38347588, 38355042, 38358582, 38358583, 38358584, 38360834, 38360835, 38366171, 38384137, 38384138, 38384139, 38392693, 38404412, 38404413, 38412000, 38412001, 38412003, 38412005, 38412006, 38412007, 38415242, 38415246, 38529822, 38531280, 38531281, 38559204, 38559205, 38559206, 38559207, 38568272, 38580272, 38580273, 38580274, 38580275, 38589983, 38589984, 38589985, 38590380, 38590381, 38590382, 38590383, 38590384, 38590385, 38590386, 38590387, 38590388, 38597090, 38623873, 38623874, 38623875, 38623876, 38632676, 38632678, 38643661, 38645060, 38645061, 38645062, 38645063, 38692073, 38692074, 38692075, 38692076, 38703597, 38708720, 38708721, 38708722, 38708723, 38712509, 38712511, 38712512, 38739451, 38739453, 38739454, 38739455, 38750004, 38750005, 38750007, 38774400, 38774401, 38802555, 38802556, 38802557, 38802558, 38809866, 38812686, 38812687, 38812688, 38821188, 38821189, 38821191, 38823209, 38823210, 38858563, 38858564, 38858565, 38858566, 38858570, 38869945, 38870375, 38870378, 38870783, 38870784, 38878535, 38878536, 38878538, 38878539, 38879225, 38879226, 38949331, 38949332, 38949333, 38949334, 39032543/30-Jul-2027 to 15-Mar-2028; RLV0075/852454006257/35490122, 35490123, 35490124, 35490125, 35490126, 35604788, 35615708, 35615709, 35705365, 35705366, 35901453, 35901454, 35901455, 35936488, 35936489, 35998826, 35998827, 35998828, 36159579, 36254921, 36349203, 36349204, 36404502, 36404503, 36421409, 36835470, 36870653, 36870654, 36874432, 36874433, 36929050, 36929051, 36929052, 36929053, 36929054, 36983480, 36983481, 37060448, 37107838, 37107839, 37191554, 37191555, 37191556, 37204731, 37210306, 37335984, 37355535, 37364022, 37535449, 37535450, 37752898, 37943227, 37976478, 37976479, 37977720, 37977721, 38048471, 38179848, 38249218, 38249700, 38249991, 38253644, 38253645, 38253670, 38253671, 38347590, 38384136, 38426598, 38451722, 38451723, 38508092, 38529821, 38531016, 38539792, 38540765, 38540766, 38655662, 38730788, 38763797, 38763799/29-Oct-2026 to 21-Nov-2027; RLV0075-EU/852454006455/36267789, 36932250, 37575378/23-Jan-2027 to 14-Aug-2027

Product quantity

37,764

Voluntary mandated

Voluntary: Firm initiated

City

Valencia

State

CA

Country

United States

Event id

98933

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